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Wendy Taylor of USAID introducing the other event partners. Photo: Marissa Chmiola/GHTC Last Wednesday 53 teams of innovators gathered at the International Trade Center in Washington, DC, for the Saving Lives at Birth DevelopmentXChange—an event resembling a cross between a science fair and an episode of Shark Tank. There were no baking soda volcanoes or smiley sponges to be found, rather innovative ideas to advance the health of pregnant women and newborns in poor communities around the world. And at stake was not a blue ribbon or a chance to take home Mr. Wonderful’s money, but something much more important—the chance to save the lives of mothers and their babies. Saving lives at birth through innovation This DevelopmentXChange served as the final stage of competition in the 5th annual Saving Lives at Birth Grand Challenges Program, a contest sponsored by the US Agency for International Development (USAID), the government of Norway, Grand Challenges Canada, and the UK Department of International Development, which aims to identify and advance groundbreaking and cost-effective solutions to improve maternal and newborn health. Innovators from around the world compete for grants to develop, test, and bring their ideas to scale. The competition covers three areas—technology development, service delivery, and demand creation. The program started in 2011 as a way to “leapfrog” solutions in the underserved area of research. “We recognized that the area of maternal and neonatal health is an area that had really not seen the type of innovation we need to save the lives of mothers and newborn around the time of birth and in the hardest to reach areas,” said Wendy Taylor, director of the Center for Accelerating Innovation and Impact at USAID. “So we put together the Saving Lives at Birth Grand Challenge…and called on the brightest minds across the world, engineers and entrepreneurs, scientists and students, to come up with new, groundbreaking ideas, new ways to prevent and treat mothers and newborns and save their lives in the most risky time—the 48 hours around the time of birth.” The response to this call has been tremendous. Since 2011, the program has provided over US$47 million in funding to 81 innovative tools and approaches, and many of the program’s successes are already having an impact as they begin to scale. To date, Saving Lives at Birth–supported innovations have been delivered to over 1.5 million women and newborns, saving at least 4,000 lives. This year the Saving Lives at Birth competition received more than 750 submissions, over half of which came from low-and middle-income countries (LMICs). Fifty-three teams were chosen to compete as finalists at the DevelopmentXChange. At the conclusion of the event, 17 award nominees were selected with additional nominees in the transition-to-scale category to be announced later this year. GHTC member projects featured as finalists Among the 53 finalists were 10 projects from GHTC member organizations: Validation of low-cost, user-friendly strip test for preeclampsia/eclampsia screening PATH Brandon Troy Leader showcases his team's innovation. Photo: GHTC/Courtney Carson Dr. Brandon Troy Leader and his team at PATH are developing a low-cost, easy-to-use strip to test for proteinuria—a key indicator of preeclampsia/eclampsia—during pregnancy. Preeclampsia is a serious health risk to both mothers and infants and accounts for at least 16 percent of maternal deaths in low-resource settings. Current diagnostics are either time-consuming and expensive—requiring 24 hour urine analysis—or inaccurate—relying on analysis of protein levels in urine which can fluctuate with fluid intake. Both of these tools are impractical for use in secondary health centers, where most women in LMICs receive treatment. The team’s innovative dipstick promises to deliver a quick, low-cost, and highly accurate test that will allow more women in low-resource settings to be diagnosed and appropriately monitored for preeclampsia/eclampsia. The strip tests for a new protein-to-creatinine (PR/CR) marker and uses a product specifically designed for this single application. It is available at less than $0.10 a strip—the current cost of the inaccurate protein-urine analysis diagnostic. In lab tests, the PR/CR strips showed 85 percent sensitivity, indicating that with appropriate clinical trials, the product could be quickly rolled out to communities in need. The team was seeking a Saving Lives at Birth validation award to test the PR/CR strips in a clinical trial with over 20,000 women and accelerate the product’s introduction into low-resource settings. Advancing introduction of new screening test for preeclampsia PATH To address the unmet need for effective screening and treatment of preeclampsia in low-resource settings, PATH is preparing for a large-scale evaluation of its innovative glycosylated fibronectin (GlyFN) test. The test targets the GlyFN biomarker, which occurs at higher concentration in the blood than other preeclampsia biomarkers and offers excellent sensitivity and specificity. Small scale tests indicate that the GlyFN test predicts preeclampsia in the third trimester of pregnancy with a sensitivity of 97 percent and specificity of 93 percent. The GlyFN test is innovative not only for its use of an easier to detect biomarker, but also for its accuracy and sensitivity in diagnosis. The PATH team was seeking a Saving Lives at Birth award to perform the first operational evaluations of the GlyFN test, refine training materials with users in the field, and implement a prospective-cohort study in Karnataka, India. Developing a model for national scale-up of the Pratt Pouch to prevent mother-to-child HIV transmission Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) A syringe typically used to measure ARV dosage and the Pratt Pouch which could replace it. Photo: GHTC/Marissa Chmiola Dr. Edward Bitarakwate and his team at EGPAF Uganda are seeking to develop a model for the national scale-up of an innovative product to prevent mother-to-child HIV transmission known as the Pratt Pouch. About 1.5 million HIV positive women give birth each year. It’s possible to prevent mother-to-child HIV transmission if antiretrovirals (ARVs) are administered during labor and for several weeks following delivery. Unfortunately, many mothers don’t give birth in health facilities so their infants fail to receive ARVs during this critical period, and those who do are currently sent home with bottles of liquid ARVs and a syringe to measure appropriate doses to administer to their child. Keeping these syringes clean can prove difficult for new moms in low-resource settings, and the viscosity of the liquid ARVs makes it challenging to measure accurate doses. The Pratt Pouch addresses these challenges—it’s an easy to tear open package containing a premeasured dose of ARVs which can be stored safely for up to 12 months at any temperature. Dr. Bitarakwate described the pouch as a “ketchup packet” for ARVs, noting that the pouch is an adaptation of technology used in the food industry to package ketchup. The pouch was developed by a team of engineers at Duke University with support from a previous Saving Lives at Birth grant. Small pilot tests of the product in individual health care settings have demonstrated promise, so Dr. Bitarakwate is seeking funding to work with the Ugandan government to integrate the product into the country’s health system and create an effective model for national scale-up of the product. Reducing birth complications by increasing access to noninvasive, cloud-connected anemia screening diagnostic device PATH Masimo's Pronto-7 anemia screening device. Photo: PATH/Patrick McKern Iron-deficiency anemia affects half of all pregnant women in LMICs and can lead to poor pregnancy outcomes including preterm births, low birth weight, and maternal mortality, contributing to one-fifth of maternal deaths. However, anemia often goes undetected, as methods commonly used throughout sub-Saharan Africa require a blood draw, which can be prohibitive to patients and must be administered by highly-trained health professionals. PATH consulted more than 100 nurses, doctors, and other health professionals in sub-Saharan Africa, hearing repeatedly “noninvasive is the future” of diagnostics. PATH has partnered with California-based diagnostic manufacturer Masimo to create a noninvasive, easy-to-use, cloud-connected diagnostic device, using the “FDA-approved guts” of Masimo’s Pronto-7 hemoglobin test. Rather than drawing blood, the health worker merely asks the patient to place their finger on the sensor (see photo) and the results are available within a minute. PATH will use Masimo’s equipment and technology, but will develop a device that is more durable and even easier to read—enabling use by lower-skilled professionals. Andy Beddoe, a product development officer at PATH, explained that diagnostics that require disposable parts are more dependent on a robust supply chain. This device, however, will require no such disposables, and will use cloud-enabled software, allowing the manufacturer to “sell tests like you would cell phone minutes,” troubleshoot, or calibrate it remotely. Beddoe believes each device could last three to four years, administering more than 50,000 tests. The software could also be used for data collection and could be adapted for use in other diagnostics. A pediatric-friendly ARV dosage form: validation of palatability, flexibility, and accurate dosing of LPV/r PATH “[We’re] targeting the most vulnerable population infected with HIV,” explains Dr. Manjari Lal, senior research officer in Vaccine and Pharmaceutical Technologies at PATH, in discussing her project. Less than a quarter of HIV-positive children in LMICs are receiving ARVs, and for most families, the current treatment method involves breaking adult doses into two, crushing up one half, and mixing it with food. Lal’s team is working to transform lopinavir/ritonavir (LPV/r)—the first-line treatment for pediatric HIV—into a product that is palatable, heat-stable, and that allows for flexible dosing. The team is developing a freeze-dried, fast-dissolving tablet, which allows a parent to mix the medicine with water—as children often struggle with pills that must be swallowed. According to Lal, palatability is a major consideration for pediatric treatments, as infants won’t hesitate to spit out bitter medicines. The treatment is currently in the preclinical phase, and must go through animal studies and clinical trials with human adults before it is ready for use in children. Scaling an Integrated Human Milk Bank and Breastfeeding promotion program in Kenya PATH Human milk provides important nutritional and disease-preventing properties for infants and is particularly critical for those who are born preterm or have low birth weight. Unfortunately, some mothers are unable to produce milk or do so in the quantity needed to feed their newborn. While it’s preferable for infants to receive their own mother’s fresh milk through breastfeeding or hand expression, in cases when that is not possible, the World Health Organization recommends the administration of human donor milk. The idea of milk banks were developed to meet this need. These banks accept donor milk, screen and process it for safety, and disseminate it to mothers in need. PATH was seeking a grant to scale-up and evaluate the impact of an innovative and integrated human milking banking approach known as Mother and Baby Friendly Initiative Plus (MBFI+). Unlike stand-alone milk banks, the MBFI+ approach creates “hubs” that provide both lactation support and milk banking at the same facility. Kimberly Amundson—program officer on PATH’s Maternal and Child Health and Nutrition Team which is leading the project—describes MBFI+ as a “self-reinforcing cycle of supporting breastfeeding for all infants.” Mothers come into the facilities for lactation support, and are then able to donate any excess milk they may produce to those who need it, and those infants who receive donor milk often go on to be able to breastfeed just fine with their own mother. The team hopes to introduce the approach at two hospitals in Kenya, evaluate its effectiveness and potential cost savings, and position the approach for national adoption. Clinical validation of a novel, affordable uterine balloon tamponade, developed in Africa, to reduce maternal deaths due to postpartum hemorrhage. PATH Postpartum hemorrhage, or severe bleeding after childbirth, is the leading cause of maternal mortality, resulting in 125,000 deaths annually. However, with just a condom and a catheter—materials readily found in health clinics—the risk can be drastically reduced. The condom—connected to the catheter—is inserted into the uterus and slowly filled with water, inducing uterine contractions and ultimately slowing or stopping the bleeding. While such a device, known as a uterine balloon tamponade, is readily available in high-income countries, it can be used just once and can cost as much as $400. PATH and partners have worked to develop a device—designed and manufactured in Sou Africa with input from health professionals—that costs just a few dollars. While condoms work well, they vary greatly and the thickness of  a condom can impact the pressure exerted by the device. This uterine balloon tamponade involves a reusable bag that is filled with water and held at a certain height—depending on how much pressure is needed—connected to a reusable catheter which is in turn connected to the disposable, standardized balloon. The device has been successfully tested and with widespread introduction, an estimated 169,000 deaths could be prevented over the next fifteen years. PATH was seeking funding to conduct a clinical validation study of the product and develop a commercialization strategy to increase access to the product in LMICs. Use of a low-cost simulation model to expand postpartum intrauterine device services Jhpiego The Mama-U simulator at the Jhpiego display. Photo: GHTC/Marissa Chmiola Over 90,000 maternal deaths can be prevented each year through family planning use. Yet, many women who have just given birth don’t receive access to long-acting family planning methods like intrauterine contraceptive devices (IUCDs) because there are not enough health providers trained to properly administer IUCDs to women with postpartum bodies; and many women incorrectly believe the product may not stay in place given the changes to their bodies resulting from birth. Under a previous grant, Jhpiego found that using a postpartum body simulator called the Mama-U was effective for training workers and improving service delivery. According to Dr. Fauzia Assad, a medical doctor working with Jhpiego Pakistan, the Mama-U offers benefits over existing approaches to training for postpartum IUCD training. “It’s cost-effective, just $50 versus $600 for the usual model, culturally appropriate, easy to take along, very portable, easy to understand, and it offers the same level of difficulty one would experience with an actual patient because it has a similar feel and tension.” In earlier testing, Jhpiego found the product was not only helpful in training providers, but counselors found it helpful in educating patients, dispelling patient concerns, and increasing client use of IUCDs. Jhpiego was seeking a grant to build on past learning and show that the Mama-U can improve quality of services and patient uptake and change the way postpartum IUCD training, counseling, and services are delivered. Projecting Health India PATH People typically find it easier to learn a process if they see it demonstrated, rather than just hearing or reading about it. This is why the Projecting Health India program is using video as a medium through which to promote health behaviors. Projecting Health India a community-based, video education project, which trains communities in India to create and produce videos addressing a variety of health topics—including birth preparedness, breastfeeding, and family planning—which are shown at community mothers’ groups and village health days. The videos feature local actors and health workers and aren’t distributed outside the district for which they were produced. Michelle Desmond, a monitoring and evaluation officer at PATH involved with the program, described the approach “as hyperlocal” which is key to the program’s effectiveness. “Literature on behavior change shows that if you can empathize with a person you see practicing a healthy behavior, you are more likely to practice it yourself,” said Desmond. “So in these videos women are seeing people who sound like them, who look like them, who are in the same situation as them practicing these health behaviors.” After realizing that the videos were so popular that women were finding ways to transfer them onto their mobile phones to rewatch and share, Projecting Health partnered with mobile phone vendors in India to allow the videos to be easily loaded onto phones, providing an additional way for these videos to be distributed to harder to reach mothers. PATH was seeking a Saving Lives at Birth grant to scale up this project in government systems throughout the state of Uttar Pradesh. NIFTY: A Neonatal Intuitive Feeding Technology for preterm infants who have difficulty breastfeeding PATH A demonstration of feeding using the NIFTY cup. Photo: GHTC/Marissa Chmiola In high-resource settings, infants who struggle with breastfeeding can be fed with breast milk through tubes or bottles, however such technologies can be expensive, difficult-to-use, or unsanitary in low-resource settings. In LMICs, the World Health Organization recommends the use of small cups for infants with feeding difficulties, including preterm infants, infants who have lost their mother due to complications in pregnancy or childbirth, and children with cleft palates. There is currently no product on the market specifically designed for this purpose, and the metal or glass cups that are often used can be inefficient, or can cause injury to the infant’s mouth including cuts. To address these limitations, PATH and its partners created the NIFTY™ cup which is made of silicone, making it soft and durable. The cup can also be boiled without causing any damage—making it easy to sterilize. The cup also has a reservoir on the lip of the cup, making it easy to control the amount of milk delivered and prevent waste. The NIFTY™ cup costs just $1.25 to produce. This innovation was chosen as one of the 17 competition award nominees. The team at PATH will use the funding to test the NIFTY™ cup in hospital settings in Ethiopia and work with private-sector partners throughout the sub-Saharan market to commercialize the cup. Innovation is happening around the world In visiting the DevelopmentXChange, it was clear that innovation is happening in all corners of the globe and lifesaving ideas can come from anywhere and anyone. Saving Lives at Birth demonstrates the power of bringing governments, foundations, academic institutions, and for-profit companies together to address our most pressing health challenges. GHTC congratulates both our members and the other teams who were selected as finalists and award nominees—your work continues to inspire us. Authored by Marissa Chmiola, GHTC’s communications officer with support from Courtney Carson, senior policy and advocacy associate, and Kat Kelley, senior program assistant.

Later this year, French pharmaceutical company Sanofi plans to launch a vaccine for dengue fever, the first on the market for an infection for which nearly half of the world’s population is at risk. Sanofi has spent more than US$1.5 billion over 20 years on the research and development (R&D) of this dengue vaccine and expects it to be not only lifesaving, but also highly profitable. Dengue fever is endemic in a number of low- and middle-income countries in Asia and Latin America and is spreading into high-income countries in southern Europe as well as Japan and the United States. In preparation for the launch, Sanofi has invested more than $300 million in a manufacturing facility for the vaccine with the capacity to produce 100 million vaccines each year. Pharmaceutical companies Takeda, Merck & Co., Inc., and GlaxoSmithKline are also developing vaccines for dengue fever, and Takeda’s candidate could be on the market by 2020. The US Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation to pharmaceutical company Bristol-Myers Squibb for its HIV treatment BMS-663068, based on the results of phase 2 clinical trials. The designation expedites FDA review in order to accelerate the availability of drugs for serious or life-threatening conditions and in cases where preliminary evidence suggests that the new product would offer significant advantages over current treatments. BMS-663068 is the first antiretroviral drug that actually prevents the HIV virus from attaching to and entering human immune cells. The designation is limited to use of the drug for “treatment-experienced” HIV patients who are developing resistance to other antiretroviral treatments. A new study suggests that the appearance of a pill can impact a patient’s perception of its efficacy. The study asked more than 100 participants each from the United States, China, and Colombia to rate images of pills on anticipated bitterness, ability to fight off headaches, and how hard it is to swallow, based solely on the shape and color of the pill. Across all three countries, participants perceived white pills as the most effective, and diamond-shaped pills—in contrast to round or oval pills—as the most difficult to swallow. A majority of US participants considered green pills to be the least effective and believed that red pills would lead to greater mental alertness. Past research has also suggested that a pill’s appearance can impact use; a study from 2014 indicates that when generic manufacturers change the shape or color of a pill, nearly one-third of patients will stop using the medication. On Monday, July 20, the Center for Global Development published The White House and the World, a report with concrete policy recommendations for the next US president on everything from energy and climate to migration and trade. The report notes that the United States often serves as the “first responder” in outbreaks and is a leader in global health, but calls for clear leadership—including the appointment of a global health coordinator—and pathways for coordination across US agencies. The report highlights the needs for reform at major multilateral organizations such as the World Health Organization and suggests that the United States should spearhead reform efforts and use those platforms to advance US priorities. The report identifies ways for the United States to provide technical assistance—through an office of Global Health Trade, Economics, and Knowledge Exchange—with partners in low- and middle-income countries, ultimately calling for a shift from the “aid-based status quo” and positioning the United States as a “forward-looking and strategic investor” in global health. The Guardian took an in-depth look at the status of antimicrobial R&D, including antibiotic drug discovery, alternative treatments for drug-resistant bacteria, and improved diagnostics. In the 1950s through the 1970s, researchers were discovering around twelve new antibiotics each year just by examining soil samples and identifying compounds—generated by the one percent of micro-organisms that can grow in normal laboratory settings—that could fight off bacteria. A new device known as iChip allows scientists to cultivate microbes while still in soil, enabling them to work with the other 99 percent of micro-organisms. Researchers at Northeastern University have identified 25 potential compounds using iChip, including one that demonstrates promise against drug-resistant tuberculosis and that the team believes could be available for use in humans within five years. According to Dr. Kim Lewis, the project’s lead researcher, “the rule of thumb is you need 50 promising leads for one drug, [so] we will keep searching for more.” Dr. Matt Cooper, a professor of chemistry at the University of Queensland, is also searching for new antimicrobial compounds. Earlier this year, he established the Community for Open Antimicrobial Drug Discovery, which will collect thousands of chemicals and test them for antibiotic potential. While Lewis and Cooper search for new compounds, others look for alternative or supplemental treatments for drug-resistant bacteria. The London-based biotech company Helperby Therapeutics has developed a “resistance breaker,” which Chief Scientific Officer Anthony Coates describes as “punching holes in the membrane of bacteria” to enhance the ability of existing antibiotics to combat the bacteria. David Livermore, a professor of medical microbiology at the University of East Anglia, is calling for rapid diagnostics to improve the diagnosis and treatment of drug-resistant infections. Livermore compares the current use of antibiotics to “carpet bombing in the second world war,” killing off all bacteria in patients, including protective bacteria in the human gut, and leaving a vacuum in which harmful bacteria can develop resistance. Because antibiotics are cheap and used by patients for a short amount of time, however, large pharmaceutical companies can be hesitant to invest in their R&D. As Cooper explains, the “low-hanging fruit[s]” have been discovered, and government investment is now needed to return to the “golden era” of antibiotic drug discovery.

An experimental, aerosol vaccine completely prevented infection from Ebola in monkeys, and will be tested in human clinical trials shortly. The vaccine was tested on twelve monkeys, with four each receiving one and two doses, two receiving a liquefied version of the vaccine, and a control group comprised of the remaining two monkeys. Four weeks after vaccination, all 12 monkeys received a massive dose of the virus, 1,000 times the fatal amount. While the two unvaccinated monkeys became ill, all ten of the vaccinated monkeys remained healthy, and the researchers found no trace of the virus in their blood. Aerosol vaccines are easy to administer and do not require a trained health professional, and thus are ideal for use in an outbreak or a country without a robust health workforce. Earlier this year, Apple Inc. launched ResearchKit, an open source software framework to facilitate the collection of health information in clinical trials, and soon two major pharmaceutical companies—GlaxoSmithKline and Purdue Pharma—may be utilizing the software. The software makes it easy for researchers to create their own iPhone applications to connect with participants in clinical trials and is already being used by academic institutions and nonprofits for data collection. Not only can these applications survey participants, but they can measure hand tremors in patients with Parkinson’s disease, physical activity in relation to cardiovascular disease, and geographic locations that exacerbate the symptoms of asthma. The software provides researchers more frequent access to a greater number of participants. Researchers are also looking into connecting other devices to the software, for example, asthma inhalers that transmit data via Bluetooth. While smartphones, and in particular iPhones, are less prevalent in low- and middle-income countries, the software could be used by health professionals or researchers for data collection. Already, smartphones are being used to perform eye exams in Kenya, pasteurize milk for breast milk banks in South Africa, and could soon be used to detect infection with Loa loa filariasis in Africa. Photo: CDC/ Dr. Mae Melvin Researchers at the Duke-NUS Graduate Medical School in Singapore have discovered an antibody—a protein in the immune system that identifies and combats specific pathogens—against one of the four viruses that causes dengue fever. The team, led by Shee-Mei Lok, a professor of Emerging Infectious Diseases at the university, first identified the specific part of the virus that triggers the production of antibodies in mice and believes that a vaccine comprised of just that part of the virus could provide protection from infection. Lok hopes to create a cocktail treatment against dengue fever using antibodies against each of the four types, and the team is continuing their research to identify an antibody against DENV-4, the one virus responsible for dengue fever for which there is not a known antibody. Bats are the natural reservoir, or host, for more than 65 viruses, bacteria, and other pathogens that infect humans, including Ebola, rabies, and the coronaviruses responsible for SARS and MERS. A team of researchers surveyed 1,270 people in rural Ghana, shedding light on the interactions between bats and humans and consequently, how these diseases are transmitted to humans. Two-thirds of respondents reported physical contact with bats, with 37 percent having been bitten, scratched, or exposed to the urine of bats. While only 17 percent of Ghanaians reported interacting with bats at work or at home, nearly half regularly visit bat caves.